化痔片的质量标准研究

Quality Standard of Huazhi Tablets

目的：建立化痔片的质量标准。方法：采用薄层色谱（TLC）法对制剂中槐米、茜草、枳壳、三七进行定性鉴别；利用高效液相色谱法测定制剂中芦丁的含量：色谱柱为Hypersil BDS C18（200mm×4．6mm，5μm），流动相为甲醇-1％冰醋酸溶液（42：58，V/V），检测波长为257nm。结果：TLC图中能清晰地鉴别出槐米、茜草、枳壳、三七的特征斑点，阴性对照无干扰。芦丁的质量浓度在10．086-504．280μg／ml范围内与峰面积积分值呈良好的线性关系（r=0．9999）；精密度、稳定性、重复性试验的RSD〈2％；平均加样回收率为99．69％，RSD=0．45％（n=6）。结论：所建标准可用于控制化痔片的质量。

OBJECTIVE ： To establish the quality standard of Huazhi tablets. METHODS ： TLC was used for identifying Sopho- ra japonica, Rubia cordifolia, Citrus aurantium and Panax notoginseng in the preparation. HPLC method was adopted to determine the content of turin. The determination was performed on Hypersil BDS C18（200 mm×4.6 ram, 5 μm） column with mobile phase consisted of methanol-l% glacial acetic acid （42：58, V/V）. The detection wavelength was set at 257 nm. RESULTS： TLC spots of them can be identified clearly without interference from negative control. The linear range of rutin were 10.086-504.280μg/ml （r= 0.999 9）; RSDs of precision, stability and reproducibility tests were all lower than 2%; average recoveries were 99.69% （RSD= 0.45 %, n = 6）. CONCLUSIONS： The standard can be used for the quality control of Huazhi tablets.